Labeling, Promotion, Off-Label Communications, and First Amendment Concerns
Scott Danzis
Partner
Covington & Burling LLP (Washington, DC)
Julie Tibbets
Partner
Alston & Bird LLP (Washington, DC)
- FDA v. FTC regulation
- Advertising v. labeling
- Restricted devices, prescription devices, and OTC devices
- FTC Requirements for Advertising
- Introduction to FTC Act
- FTC requirements for substantiation of health claims
- FTC requirements for endorsements
- FDA Regulation of Promotion
- Reviewing FDA’s two recent Guidances on communications related to medical devices
- “Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities”
- “Medical Product Communications That Are Consistent With the FDA-Required Labeling”
- Reviewing FDA’s two recent Guidances on communications related to medical devices
- Analyzing FDA’s position on First Amendment
- Examining FDA’s “Memorandum: Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products”